MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NGE-017115

Device Problems Break (1069); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The area representative reported during a ureteroscopy with stent and stone removal procedure the ngage nitinol stone extractor was used.The physician removed two stones, then the basket became inoperable.The tip of the basket seemed to have broken, as it appeared there were only three loops.The physician used another to complete the procedure.There was no harm to the patient and nothing broke off inside of the patient.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional patient, device and event information has been requested.

Manufacturer Narrative

Investigation - evaluation: a document based investigation was performed which included a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications was performed.Visual inspection and functional testing of the returned device was also conducted.One ngage nitinol stone extractor was returned for evaluation.The device was returned with the handle in the open position and the basket formation is partially closed.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A visual examination noted the support sheath is bent over at the nose of the mlla.No other kinks noted in the basket sheath.A functional test noted the handle actuated the basket formation; however, the basket formation does not open and close completely.The cannulated handle is bent.The wires in the basket formation are twisted.They have the appearance of getting ¿caught¿ or ¿hooked¿ on something.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and two non-conformances were identified.The non-conformances were unrelated to the reported failure mode.A review of complaint history revealed there have been no other complaints received associated with this complaint device lot number 7202789.Based on the provided information a definitive root cause cannot be established or reported.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6829607
• MDR Text Key: 83993535
• Report Number: 1820334-2017-02774
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)190816(10)7202789
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1